METRONIDAZOLE tablet, film coated
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
22-12-2015
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Active ingredient:
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
Available from:
Apotheca Inc.
INN (International Name):
METRONIDAZOLE
Composition:
METRONIDAZOLE 500 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to tr
Product summary:
Metronidazole Tablets USP, 250 mg White colored, round shaped, film coated, biconvex tablets with 'U' debossed on one side and '226' debossed on other side. Bottles of 50: NDC 29300-226-46 Bottles of 100: NDC 29300-226-01 Bottles of 250: NDC 29300-226-52 Bottles of 500: NDC 29300-226-05 Bottles of 1000: NDC 29300-226-10 Metronidazole Tablets USP, 500 mg White colored, capsule shaped, film coated biconvex tablets with 'U' debossed on one side and '227' debossed on other side. Bottles of 50: NDC 29300-227-46 Bottles of 100: NDC 29300-227-01 Bottles of 500: NDC 29300-227-05 Bottles of 1000: NDC 29300-227-10 Storage and Stability: Store at 20 0 C to 25 0 C (68 0 to 77 0 F) [See USP Controlled Room Temperature]. Protect from light.
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
METRONIDAZOLE- METRONIDAZOLE TABLET, FILM COATED
APOTHECA INC.
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METRONIDAZOLE TABLETS USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
tablets and other antibacterial drugs, metronidazole tablets should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats (see
PRECAUTIONS).
Unnecessary use of the drug should be avoided. Its use should be
reserved for the conditions
described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the
synthetic nitroimidazole
antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the
following structural formula:
Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole.
Inactive ingredients include
powdered cellulose, hydroxypropyl cellulose, low substituted
hydroxypropyl cellulose, hypromellose,
polyethylene glycol, stearic acid, and titanium dioxide.
CLINICAL PHARMACOLOGY
ABS ORPTION
Disposition of metronidazole in the body is similar for both oral and
intravenous dosage forms.
Following oral administration, metronidazole is well absorbed, with
peak plasma concentrations
occurring between one and two hours after administration.
Plasma concentrations of metronidazole are proportional to the
administered dose. Oral administration
of 250 mg, 500 mg, or 2,000 mg produced peak plasma concentrations of
6 mcg/mL, 12 mcg/mL, and 40
mcg/mL, respectively. Studies reveal no significant bioavailability
differences between males and
females; however, because of weight differences, the resulting plasma
levels in males are generally
lower.
DIS TRIBUTION
Metronidazole is the major component appearing in the plasma, with
lesser quantities of metabolites also
being present. Less than 20% of the circulating metronidazole is bound
to plasma proteins.
Metronidazole appears in cerebrospinal fluid, saliva, and breast milk
in
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